Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1 esterase inhibitor for the acute management of subarachnoid hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies
研究概览
简要总结
To study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan
- •Age of 18 years or above
- •WFNS grade 1-5
排除标准
- •Subarachnoid hemorrhage deemed most likely of peri mesencephalic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)
- •Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)
- •Participation in another clinical therapeutic study
- •Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
- •Patients with a known hereditary complement deficiency (including hereditary angioedema)
- •Patients with a history of sensibility to blood products or C1-inhibitor
- •Patients with a know history of thrombosis (when known at time of inclusion)
- •Pregnant women
结局指标
主要结局
Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies
Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies
Number of participants with complications during hospitalization
Number of participants with complications during hospitalization
次要结局
- Mortality
- Cerebral infarction on brain CT at 14 days
- Daily neurological condition measured bij GCS during the first 14 days
- Complement activity in serum and CSF
- Coagulation cascade activation
- ICU length of stay
- Ventilator days
研究者
Clinical trial information desk
Scientific
Haaglanden Medisch Centrum Stichting